Wound of SkinNCT03061461
Radial Extracorporeal Shock Wave Therapy for Chronic Soft Tissue Wounds
A study testing rESWT in people with Wound of Skin, run by Kuala Lumpur General Hospital at 1 site in Malaysia.
Trial summary
This study tests the hypothesis that radial extracorporeal shock wave therapy (rESWT) as performed by Zoech (JATROS Orthop 2009;(1):46-47) is effective and safe in treatment of chronic soft tissue wounds, and is statistically significantly more effective than sham-treatment of chronic soft tissue wounds. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Wound of Skin
- What is being tested?
- rESWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- 23 Feb 2017to 15 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults (both male and female) with chronic soft tissue wounds
- age range: between 18 and 80 years
- willingness of the patient to participate in the study, and written informed consent signed and personally dated by the patient
- different kinds of chronic soft tissue wounds: diabetic foot ulcers, post traumatic, venous stasis ulcer, decubitus
- wounds scored as Grade/Stage 1A, 1C, 2A and 2C according to Armstrong et al. (Diabetes Care 1998;21:855-859)
- No contraindications for rESWT
Who cannot join
- children and teenagers below the age of 18
- no willingness of the patient to participate in the study, and/or written informed consent not signed and not personally dated by the patient
- wounds scored as Grade/Stage 0A, 0B, 0C, 0D, 1B, 1D, 2B, 2D, 3A, 3B, 3C or 3D according to Armstrong et al. (1998)
- Burn wounds
- Uncontrolled diabetes because glycaemic control is crucial for wound healing and erratic values will effect the study results
- Blood sugar levels of the patient before meals are NOT regularly higher than 7mmol/L and are NOT regularly higher than 11mmol/L one to two hours after meals)
- Contraindications of rESWT: treatment of (i) soft tissue wounds over air-filled tissue (lung, gut), (ii) pregnant patients, (iii) patients with blood-clotting disorders (including local thrombosis), (iv) patients treated with oral anticoagulations, (v) soft tissue wounds above local tumors, and (vi) patients treated with local corticosteroid applications in the time period of six weeks before the first rESWT session (if applicable).
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Wound Care Unit, Dept. of Internal Medicine, Kuala Lumpur Hospital
Kuala Lumpur
Karina Koh, MD, +6-03-2615 5555 ext. 1783, karinakoh@crc.moh.gov.my
About this study
Official title: A Prospective, Randomized, Double-blind, Placebo Controlled, Parallel Group, Single Center Trial to Assess the Efficacy and Safety of Radial Extracorporeal Shock Wave Therapy in Subjects With Chronic Soft Tissue Wounds
This study tests the hypothesis that radial extracorporeal shock wave therapy (rESWT) as performed by Zoech (JATROS Orthop 2009;(1):46-47) is effective and safe in treatment of chronic soft tissue wounds, and is statistically significantly more effective than sham-treatment of chronic soft tissue wounds.
Read the detailed description
Zoech (2009) treated in a feasibility study a total of n=18 patients affected by 21 ulcers in Stage IA or IIA (according to Armstrong and colleagues, Diabetes Care 1998;21:855-859) with repetitive radial extracorporeal shock wave therapy (rESWT) using the Swiss DolorClast device (Electro Medical Systems S.A., Nyon, Switzerland). The wounds had been observed for more than 6 weeks. In nine cases the wounds were located in non-loaded areas such as the edge of the foot, or appeared after previous toe amputation. In 12 cases the wounds were located on the sole, the toes or the heel; in these cases the average area of the wounds was 351 mm^2 (116 to 599 mm^2). Local wound treatment consisted of regular debridement by scalpel, followed by disinfection with sterile saline solution and application of wet treatment adequate to the stage of the wounds. Depending on the amount of secretion, the depth of the ulcer and the healing stages, different bandage materials were used. Besides this, rESWT was applied at intervals depending on the size and the depth of the ulcers, once or twice a week for three to six weeks, with 1,000 impulses per cm^2 and treatment session with positive energy flux density (EFD) of 0.1 mJ/mm^2. To this end ulcers were covered with sterile drape in order to avoid direct contact of ultrasound jelly and the handpiece of the rESWT device with the ulcers. After further disinfection with sterile saline solution, bandage was applied. The state of the ulcers was documented photographically at regular intervals and the size of the ulcers were evaluated with digital image analysis. Wounds were evaluated after the first, second and third week. Zoech (2009) noted that rESWT caused no pain, and neither local or generalized infections were observed throughout the observation period. Sixteen out of the 21 wounds healed within a mean period of six weeks (range: 3 to 9 weeks). In three cases, sufficient granulation tissue was formed after eight weeks on average, allowing for wound covering by gap tissue transplant. On average the size of the ulcers was reduced to 67% (20-100%) after the first week, 53% (15-90%) after the second week and 35% (9-78%) after the third week compared to baseline. These data indicate that the application of repetitive rESWT using the Swiss DolorClast is a low-effort and effective complement to standard therapy in diabetic foot ulcers without signs of infection or ischemia. In the study by Zoech (2009) patients were specifically very satisfied by the good tolerability and the absence of any significant side effects.
However, Zoech (2009) did not investigate a control group. Accordingly, it is currently unknown whether rESWT as performed by Zoech (2009) is more effective than sham-treatment of chronic soft tissue wounds. The present study was designed to answer this question.
- Conditions
- Wound of Skin
- Being tested
- rESWT, Sham rESWT
- Keywords
- Extracorporeal shock wave therapy, ESWT, Radial extracorporeal shock wave therapy, rESWT, Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rESWTDevice
All patients will receive standard care as follows:
- Wounds will be cleaned with distilled water and applied with collagen gel or collagen sheet on the wound and then closed with foam/gauze or gamgee.
- The clean wounds will be assessed using the TIME concept.
- Treatment with rESWT.
- Subsequently the wounds will be cleansed with distilled water, and collagen and glycerine gel will be applied and covered with adhesive dressings (Melolin, Smith \& Nephew, Inc. Advanced Wound Management; Fort Worth, TX, USA).
In addition, patients in arm "rESWT" will receive rESWT between Steps 2 and 3 of standard care as outlined in arm description "rESWT".
Sham rESWTDevice
All patients will receive standard care as follows:
- Wounds will be cleaned with distilled water and applied with collagen gel or collagen sheet on the wound and then closed with foam/gauze or gamgee.
- The clean wounds will be assessed using the TIME concept.
- Treatment with sham rESWT.
- Subsequently the wounds will be cleansed with distilled water, and collagen and glycerine gel will be applied and covered with adhesive dressings (Melolin).
In addition, patients in arm "Sham rESWT" will receive sham rESWT between Steps 2 and 3 of standard care as outlined in arm description "Sham rESWT".
| Study group | Role | What they receive |
|---|---|---|
| rESWT | Active comparator | Treatment of chronic wounds with the Swiss DolorClast (Electro Medical Systems S.A., Nyon, Switzerland) and the EvoBlue handpiece as follows:
* Use of the 15-mm applicator or the 36-mm applicator of the Swiss DolorClast according to the individual wound size.
* Six treatment sessions, two treatment sessions per week.
* 1000 radial shock waves per cm^2 wound and treatment session.
* Energy flux density 0.07 mJ/mm^2 (i.e., setting of the air pressure of the Swiss DolorClast at 2 bar when using the 15-mm applicator, and at 4 bar when using the 36-mm applicator).
* Frequency of the radial shock waves set at 15 Hz. Receives: Device: rESWT |
| Sham rESWT | Sham comparator | Treatment of chronic wounds with the Swiss DolorClast (Electro Medical Systems S.A., Nyon, Switzerland) and the placebo EvoBlue handpiece of the Swiss DolorClast (that looks and sounds like the EvoBlue handpiece of the Swiss DolorClast, but does not generate radial shock waves) as follows:
* Use of the 15-mm applicator or the 36-mm applicator of the Swiss DolorClast according to the individual wound size.
* Six treatment sessions, two treatment sessions per week.
* 1000 sham radial shock waves per cm^2 wound and treatment session.
* Energy flux density 0.00 mJ/mm^2 (setting of the air pressure of the Swiss DolorClast at 2 bar when using the 15-mm applicator, and at 4 bar when using the 36-mm applicator).
* Frequency of the sham radial shock waves set at 15 Hz. Receives: Device: Sham rESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound size
Individual time necessary to convert a chronic soft tissue wound from Grade/Stage 1A, 1C, 2A or 2C according to Armstrong et al. (Diabetes Care 1998;21:855-859) into Grade/Stage 0A or 0C according to Armstrong et al. (1998) (i.e., lesion completely epithelialized).
Measured: Three months after start of the treatments
Secondary outcomes (3)
Comfort during treatment
Individual patient's comfort during treatment will be assessed using a scale ranging from 0 (maximum discomfort) to 10 (maximum comfort).
Measured: Immediately after each treatment session
Pain intensity during treatment
Individual patient's pain during treatment will be assessed using a scale ranging from 0 (no pain at all) to 10 (maximum, unbearable pain).
Measured: Immediately after each treatment session
Satisfaction
Individual patient's satisfaction at three months after the start of the treatments will be assessed using a scale ranging from 0 (maximum dissatisfaction) to 10 (maximum satisfaction).
Measured: Three months after start of the treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start23 Feb 2017
- Primary completion15 Dec 2017 (estimated)
- Study completion15 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound of SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled trial (RCT), no blinding of therapists applying the treatments, blinding of patients, blinding of evaluators. Partial cross-over design: patients in the control group will be offered to be treated with rESWT starting three months after the last sham treatment. This will guarantee that every patient will receive a real rESWT treatment independent of blind allocation to one of the treatment groups.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuala Lumpur General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Harikrishna K.Ragavan Nair, Kuala Lumpur General Hospital
- Investigators
- Harikrishna KR Nair, MD, Principal investigator, Hospital Kuala Lumpur, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061461
- Sponsor's protocol ID
- NMRR-16-1660-32178 (IIR)
- Status last verified
- Feb 2017
- First submitted
- 19 Feb 2017
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Placebo Controlled, Parallel Group, Single Center Trial to Assess the Efficacy and Safety of Radial Extracorporeal Shock Wave Therapy in Subjects With Chronic Soft Tissue Wounds
- ClinicalTrials.gov ID
- NCT03061461
- Acronym / sponsor ID
- NMRR-16-1660-32178 (IIR)
- Conditions
- Wound of Skin
- Keywords
- Extracorporeal shock wave therapy, ESWT, Radial extracorporeal shock wave therapy, rESWT, Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kuala Lumpur General HospitalOther government
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 15 Dec 2017 (estimated)
- Study completion
- 15 Dec 2017 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests the hypothesis that radial extracorporeal shock wave therapy (rESWT) as performed by Zoech (JATROS Orthop 2009;(1):46-47) is effective and safe in treatment of chronic soft tissue wounds, and is statistically significantly more effective than sham-treatment of chronic soft tissue wounds.
Detailed description
Zoech (2009) treated in a feasibility study a total of n=18 patients affected by 21 ulcers in Stage IA or IIA (according to Armstrong and colleagues, Diabetes Care 1998;21:855-859) with repetitive radial extracorporeal shock wave therapy (rESWT) using the Swiss DolorClast device (Electro Medical Systems S.A., Nyon, Switzerland). The wounds had been observed for more than 6 weeks. In nine cases the wounds were located in non-loaded areas such as the edge of the foot, or appeared after previous toe amputation. In 12 cases the wounds were located on the sole, the toes or the heel; in these cases the average area of the wounds was 351 mm^2 (116 to 599 mm^2). Local wound treatment consisted of regular debridement by scalpel, followed by disinfection with sterile saline solution and application of wet treatment adequate to the stage of the wounds. Depending on the amount of secretion, the depth of the ulcer and the healing stages, different bandage materials were used. Besides this, rESWT was applied at intervals depending on the size and the depth of the ulcers, once or twice a week for three to six weeks, with 1,000 impulses per cm^2 and treatment session with positive energy flux density (EFD) of 0.1 mJ/mm^2. To this end ulcers were covered with sterile drape in order to avoid direct contact of ultrasound jelly and the handpiece of the rESWT device with the ulcers. After further disinfection with sterile saline solution, bandage was applied. The state of the ulcers was documented photographically at regular intervals and the size of the ulcers were evaluated with digital image analysis. Wounds were evaluated after the first, second and third week. Zoech (2009) noted that rESWT caused no pain, and neither local or generalized infections were observed throughout the observation period. Sixteen out of the 21 wounds healed within a mean period of six weeks (range: 3 to 9 weeks). In three cases, sufficient granulation tissue was formed after eight weeks on average, allowing for wound covering by gap tissue transplant. On average the size of the ulcers was reduced to 67% (20-100%) after the first week, 53% (15-90%) after the second week and 35% (9-78%) after the third week compared to baseline. These data indicate that the application of repetitive rESWT using the Swiss DolorClast is a low-effort and effective complement to standard therapy in diabetic foot ulcers without signs of infection or ischemia. In the study by Zoech (2009) patients were specifically very satisfied by the good tolerability and the absence of any significant side effects.
However, Zoech (2009) did not investigate a control group. Accordingly, it is currently unknown whether rESWT as performed by Zoech (2009) is more effective than sham-treatment of chronic soft tissue wounds. The present study was designed to answer this question.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial (RCT), no blinding of therapists applying the treatments, blinding of patients, blinding of evaluators. Partial cross-over design: patients in the control group will be offered to be treated with rESWT starting three months after the last sham treatment. This will guarantee that every patient will receive a real rESWT treatment independent of blind allocation to one of the treatment groups.
| Arm | Type | Receives |
|---|---|---|
| rESWT | Active comparator | Device: rESWTTreatment of chronic wounds with the Swiss DolorClast (Electro Medical Systems S.A., Nyon, Switzerland) and the EvoBlue handpiece as follows: * Use of the 15-mm applicator or the 36-mm applicator of the Swiss DolorClast according to the individual wound size. * Six treatment sessions, two treatment sessions per week. * 1000 radial shock waves per cm^2 wound and treatment session. * Energy flux density 0.07 mJ/mm^2 (i.e., setting of the air pressure of the Swiss DolorClast at 2 bar when using the 15-mm applicator, and at 4 bar when using the 36-mm applicator). * Frequency of the radial shock waves set at 15 Hz. |
| Sham rESWT | Sham comparator | Device: Sham rESWTTreatment of chronic wounds with the Swiss DolorClast (Electro Medical Systems S.A., Nyon, Switzerland) and the placebo EvoBlue handpiece of the Swiss DolorClast (that looks and sounds like the EvoBlue handpiece of the Swiss DolorClast, but does not generate radial shock waves) as follows: * Use of the 15-mm applicator or the 36-mm applicator of the Swiss DolorClast according to the individual wound size. * Six treatment sessions, two treatment sessions per week. * 1000 sham radial shock waves per cm^2 wound and treatment session. * Energy flux density 0.00 mJ/mm^2 (setting of the air pressure of the Swiss DolorClast at 2 bar when using the 15-mm applicator, and at 4 bar when using the 36-mm applicator). * Frequency of the sham radial shock waves set at 15 Hz. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adults (both male and female) with chronic soft tissue wounds
- age range: between 18 and 80 years
- willingness of the patient to participate in the study, and written informed consent signed and personally dated by the patient
- different kinds of chronic soft tissue wounds: diabetic foot ulcers, post traumatic, venous stasis ulcer, decubitus
- wounds scored as Grade/Stage 1A, 1C, 2A and 2C according to Armstrong et al. (Diabetes Care 1998;21:855-859)
Key exclusion criteria (7 listed)
- children and teenagers below the age of 18
- no willingness of the patient to participate in the study, and/or written informed consent not signed and not personally dated by the patient
- wounds scored as Grade/Stage 0A, 0B, 0C, 0D, 1B, 1D, 2B, 2D, 3A, 3B, 3C or 3D according to Armstrong et al. (1998)
- Burn wounds
- Uncontrolled diabetes because glycaemic control is crucial for wound healing and erratic values will effect the study results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rESWTAll patients will receive standard care as follows: 1. Wounds will be cleaned with distilled water and applied with collagen gel or collagen sheet on the wound and then closed with foam/gauze or gamgee. 2. The clean wounds will be assessed using the TIME concept. 3. Treatment with rESWT. 4. Subsequently the wounds will be cleansed with distilled water, and collagen and glycerine gel will be applied and covered with adhesive dressings (Melolin, Smith \& Nephew, Inc. Advanced Wound Management; Fort Worth, TX, USA). In addition, patients in arm "rESWT" will receive rESWT between Steps 2 and 3 of standard care as outlined in arm description "rESWT". | Device | rESWT |
| Sham rESWTAll patients will receive standard care as follows: 1. Wounds will be cleaned with distilled water and applied with collagen gel or collagen sheet on the wound and then closed with foam/gauze or gamgee. 2. The clean wounds will be assessed using the TIME concept. 3. Treatment with sham rESWT. 4. Subsequently the wounds will be cleansed with distilled water, and collagen and glycerine gel will be applied and covered with adhesive dressings (Melolin). In addition, patients in arm "Sham rESWT" will receive sham rESWT between Steps 2 and 3 of standard care as outlined in arm description "Sham rESWT". | Device | Sham rESWT |
Primary outcome
Wound size
Time frame: Three months after start of the treatments
Individual time necessary to convert a chronic soft tissue wound from Grade/Stage 1A, 1C, 2A or 2C according to Armstrong et al. (Diabetes Care 1998;21:855-859) into Grade/Stage 0A or 0C according to Armstrong et al. (1998) (i.e., lesion completely epithelialized).
3 secondary outcomes
Comfort during treatment
Time frame: Immediately after each treatment session
Pain intensity during treatment
Time frame: Immediately after each treatment session
Satisfaction
Time frame: Three months after start of the treatments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harikrishna KR Nair, MD principal investigator
Hospital Kuala Lumpur, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rESWT in people with Wound of Skin, run by Kuala Lumpur General Hospital at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harikrishna KR Nair, MD (+6-12-2920235, hulk25@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound size (time frame: Three months after start of the treatments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.